Condition: Radiculopathy Lumbar · Degenerative Lumbar Disc Disease · Sponsor: Providence Medical Technology, Inc.
The goal of this clinical trial is to assess the safety and effectiveness of the study device, CORUS-LX, as an adjunct to lumbar interbody fusion, when used in combination with pedicle screw and rod constructs for the treatment of lumbosacral degenerative disease in patients requiring 2 level (L4-S1) lumbar fusion, for the treatment of symptomatic degenerative lumbosacral disc disease. The main questions it aims to answer are: Is there fusion success at the treated posterior anatomy of each level? Is there an absence of major adverse device related events? Is there an absence of injections (steroid, facet joint, nerve block) or subsequent revision surgery at index levels for symptoms related to back or leg pain? Researchers will compare a control arm to the treatment arm to see if research results vary from standard minimally invasive supplemental posterior fusion. Eligible participants will undergo one of the below interventions: * Two-level lumbar interbody fusion at L4-L5 \& L5-S1 segments, with supplemental posterior fusion performed using the study device, including pedicle screw and rod fixation. * Two-level lumbar interbody fusion at L4-L5 \& L5-S1 segments, with standard minimally invasive supplemental posterior fusion including pedicle screw and rod fixation. Participants will also be asked to read, understand, and sign the informed consent, attend a Screening/Baseline visit, undergo surgery for their designated intervention, and participate in 5 additional stud…
This description comes directly from the study's public registry record.
Erik M Summerside, PhD · (415) 923-9376 · ILIF@providencemt.com
Always discuss trial participation with your own doctor first.
| Barrow Brain & Spine | Scottsdale, Arizona, United States | Recruiting |
| HonorHealth Neurology | Scottsdale, Arizona, United States | Recruiting |
| California Spine | Los Angeles, California, United States | Recruiting |
| Golden State Orthopedics & Spine | Los Gatos, California, United States | Recruiting |
| Orthopaedic Spine Institute | Hinsdale, Illinois, United States | Recruiting |
| Hospital for Special Surgery | New York, New York, United States | Recruiting |
| Olympia Neurological Institute | Austin, Texas, United States | Not Yet Recruiting |
| Spine Physician Institute | Dallas, Texas, United States | Terminated |
| American Neurospine Institute | Frisco, Texas, United States | Recruiting |
| Huntsman Spine | Salt Lake City, Utah, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07222787